MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE® LIFEBAND; CHEST COMPRESSION ASSEMBLY

Model Number 8700-0701-01

Device Problems Material Integrity Problem (2978); Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/04/2019

Event Type  malfunction  

Manufacturer Narrative

Zoll has not received the lifeband for investigation.A supplemental report will be filed when the product is returned and the investigation has been completed.The death was not related to the autopulse device.The autopulse is used as an adjunct to manual cpr in cases of clinical death.The benefit of using the autopulse is that it in part substitutes mechanical compressions for the physical labor of manual chest compressions.If the autopulse did not start or unexpectedly stops compressions, rescuer should revert to manual cpr, which is the standard of care.In this case, the autopulse platform (sn (b)(4)) was performing compressions without any issue until crew paused the platform for a rhythm check on the patient.When the platform resumed its compressions, the platform made a loud noise and the lifeband flew off the device.The crew reverted to manual cpr immediately.Rosc was not achieved and the patient was expired.The autopulse was intended to be used as an adjunct to manual cpr on adult patients.In case of stoppage of autopulse the user reverts to manual cpr.The transition from autopulse to manual cpr by trained users is similar to the time necessary for rescuer rotation, and presents the same workflow as manual cpr.Hence, based on available information, the patients' outcome was not negatively impacted by the interruptions when compared to standard of care manual cpr.

Event Description

During patient use, the autopulse platform (sn (b)(4)) was performing compressions without any issue.The crew paused the platform for a rhythm check on the patient.When the platform resumed its compressions, the platform made a loud noise and the lifeband flew off the device.The crew noticed that the right hand side of the platform where the lifeband connects was broken and the lifeband was ripped on the right side.Immediately the crew reverted to manual cpr.Rosc was not achieved and the patient was expired.Please see the following related mfr report: mfr # 3010617000-2019-00335 for the autopulse platform.

Manufacturer Narrative

Zoll has received the lifeband (lot # 77432) for investigation.A supplemental report will be filed when the investigation has been completed.

Event Description

During patient use, the autopulse platform (sn (b)(4) was performing compressions without any error or fault.The crew paused the platform for a rhythm check on the patient.When the platform resumed its compressions, the platform made a loud noise and the lifeband flew off the device.The crew noticed that the right hand side of the platform where the lifeband connects was broken and the lifeband was ripped on the right side.Immediately the crew reverted to manual cpr.The manual cpr was performed for approximately 30 minutes with minimal time taken for rhythm checks.Rosc was not achieved and the patient was pronounced dead at his home.The patient was 38 years old male, weighed 220 lbs with no previous medical history and no medications.The patient had a flu-like symptoms on a day before the cardiac arrest.The cause of patient's death is unknown.Per user, the patient's death was not related to the autopulse platform.Please see the following related mfr report: mfr # (b)(4) for the autopulse platform.

Event Description

Please see the following related mfr report: mfr # 3010617000-2019-00335 for the autopulse platform.

Manufacturer Narrative

The reported complaint of "the lifeband (lot # 77432) flew off from the autopulse platform and the lifeband was ripped on the right side" was not confirmed during the visual inspection and functional testing.No device malfunction was observed during the evaluation and the lifeband performed as intended.Upon visual inspection, no physical damage was observed.During functional testing, the lifeband was tested using the returned autopulse platform with the large resuscitation test fixture (lrtf) equivalent to 250 lbs.For two hours without any fault or error.

• Brand Name: AUTOPULSE® LIFEBAND
• Type of Device: CHEST COMPRESSION ASSEMBLY
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave,; san jose CA 95131
• MDR Report Key: 8542457
• MDR Text Key: 142858956
• Report Number: 3010617000-2019-00369
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111001571
• UDI-Public: 00849111001571
• Combination Product (y/n): N
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 11/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8700-0701-01
• Device Catalogue Number: 8700-0701-01
• Device Lot Number: 77432
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2019
• Date Manufacturer Received: 10/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 38 YR
• Patient Weight: 100